FDA Inspection 1208871 — Celgene Corporation
The FDA completed an inspection of Celgene Corporation on June 16, 2023 in Summit, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Summit, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |